APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

Main information

  • Trade name:
  • APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 179020
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

179020

APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

27/09/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

Product Type

Single Medicine Product

Effective date

21/04/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

?Treatment of hypertension. (Data are currently not available to support the use of ramipril in renovascular hypertension).,?Post MI heart

failure.,?Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1 g/day.,?For reducing the risk of myocardial

infarction, stroke, cardiovascular death or the need for revascularisation procedures in patients 55 years of age or more who have clinical evidence of

coronary artery disease, stroke or peripheral vascular disease.,?For reducing the risk of myocardial infarction, stroke, cardiovascular death or

revascularisation procedures in diabetic patients 55 years or more with one or more of the following risk factors: systolic blood pressure > 160 mm Hg or

diastolic blood pressure > 90 mm Hg (or on antihypertensive treatment); total cholesterol > 5.2 mmol/L; HDL cholesterol < 0.9 mmol/L; current smoker;

known microalbuminuria; any evidence of previous vascular disease.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

24 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

Components

1. APOTEX-RAMIPRIL ramipril 1.25mg capsule bottle

Dosage Form

Capsule

Route of Administration

Oral

Visual Identification

yellow cap & white body imprinted with APO 1.25 in black ink

Active Ingredients

Ramipril

1.25 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 09:41:35 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information